Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Head, Neck, 04-070
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: fluorine-18-labeled fluoro-misonidazole (18F-FMISO) Type: Radiation
Name: 18F-FMISO PET scan Type: Device
Name: MRI Type: Device
Name: FDG PET/CT scan Type: Device
Overall Status
Recruiting
Summary
The purpose of this study is to evaluate low oxygen areas called hypoxia within tumors. These low oxygen areas are thought to be the reason why tumors are more resistant to chemotherapy and radiation treatment.

A recent imaging technique using a hypoxia tracer called fluoromisonidazole (FMISO) can detect low oxygen areas within a tumor. This imaging technique, called a PET scan, uses positively charged particles to detect slight changes in the body's biochemistry and metabolism. FMISO PET scans have been performed in patients with head and neck cancer and have shown the ability to detect low oxygen areas within tumors.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria for Cohort 1 and Cohort 2 :

- Histologically confirmed diagnosis of head and neck carcinoma (excluding nasopharynx, paranasal sinus, salivary, and thyroid malignancies)Any unknown primary squamous cell carcinoma of head and neck with gross nodes is allowed (2002 AJCC)

- 18 years of age or older

- Must not have received prior radiation therapy or chemotherapy for this diagnosis. Patients who have had their primary site tumor removed by surgery but still present with grossly enlarged lymph nodes are eligible for this study.

- Karnofsky performance status ≥ 70.

Exclusion Criteria for Cohort 1 and Cohort 2:

- all nasopharyngeal, paranasal sinus, salivary cancer, and thyroid malignancies

- prior chemotherapy or radiotherapy within the last three years

- patients that underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged lymph nodes)

- any prior radiotherapy to the head and neck region

- pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding

Subject Exclusion Criteria for Optional Contrast MRIs - Cohort 1 Only

• Subjects with a known contraindication to the standard MRI contrast agent (Gadavist, a gadolinium-based contrast agent) and/or a recent estimated glomerular filtration rate (eGFR) of 30 or less will be excluded from all DCE-MRIs, and will instead receive non-contrast MRIs at the DCE-MRI time points.
Locations
Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States
Status: Recruiting
Contact: Nancy Lee, MD - 212-639-3341
Memorial Sloan Kettering Cancer Center at Commack
Commack, New York, United States
Status: Recruiting
Contact: Nancy Lee, MD - 212-639-3341
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Nancy Lee, MD - 212-639-3341
Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, United States
Status: Recruiting
Contact: Nancy Lee, MD - 212-639-3341
Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, United States
Status: Recruiting
Contact: Nancy Lee, MD - 212-639-3341
Memorial Sloan Kettering West Harrison
West Harrison, New York, United States
Status: Recruiting
Contact: Nancy Lee, MD - 212-639-3341
Start Date
June 2004
Completion Date
June 2016
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page